Quality Control Scientist

Califesciences; Vista (CA); Hybrid; USD 41,000 - 91,000; Full time

Benefits offered by this job

Annual bonus

Medical/Dental/Vision coverage

401(k) plan

Job summary

Bachem Americas, Inc. in Vista, CA, is seeking a Quality Control Scientist to perform daily QC operations, test raw materials and final products, and maintain cGMP documentation under supervision.

The role requires a chemistry degree, 3+ years GMP pharma/biotech experience, and hands-on use of HPLC/UPLC, GC, Mass Spectrometry, UV-Vis, and related analytical equipment. Shift: 5:00am–3:30pm, Sun–Wed.

Qualifications

• Bachelor's degree in chemistry or related field.
• Master's degree in chemistry or related field preferred.
• Minimum of 3 years' experience in GMP pharma/biotech facility.

Responsibilities

• Maintain and perform daily QC operations coordinating with QC Director/Supervisor.
• Test raw materials, final product, and in-process controls for GMP compliance.
• Write and revise specifications, SOPs, STMs, and other GMP documents.
• Perform analytical work with HPLC/UPLC, GC, UV, and Mass Spec instruments.
• Maintain QC equipment verification and calibration per GMP standards.
• Investigate deviations and support validation activities for QC analyses.

Skills

Attention to detail

Communication skills

Time management

Independent work

Education

Bachelor's degree in chemistry

Master's degree in chemistry

Tools

GC

HPLC/UPLC

UV-Vis spectrophotometer

Mass spectrometry

Equipment maintenance programs

Job description

All qualified applicants will receive consideration for employment without regard to race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, or other legally protected status

Bachem Americas, Inc.

Bachem is a leading, innovation-driven company specializing in the development and manufacture of peptides and oligonucleotides. With over 50 years of experience and expertise Bachem provides products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide and offers a comprehensive range of services. Bachem operates internationally with headquarters in Switzerland and locations in Europe, the US and Asia. The company is listed on the SIX Swiss Exchange. For further information, see www.bachem.com.

A brief overview

The Quality Control Scientist performs laboratory day-today operations, guides and interacts with QC and department personnel to accomplish goals and objectives as directed by supervisor. Other duties include performing raw material testing, final product testing, QC documentation and related GMP activities.

Shift: 5:00am - 3:30pm, Sunday - Wednesday (4x10)

What you will do

• Maintain and perform daily operations in coordination with the QC Director/Supervisor to include testing of raw material/peptide samples and prioritizing projects
• Write and work with other QC Staff and other Department in the creation and approval of control documents such as specifications, SOPs, STMs, etc.
• Maintain and perform regular verification of the QC equipment for GMP compliance regularly in coordination with QC Director / Supervisor
• Implement and maintain GMP procedures such as following SOP's, Standard Testing Procedures (STP's), written procedure and maintaining proper documentation as necessary for Quality Control
• Test, review, and release raw material used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
• Receive, test and release final product peptide manufactured at Bachem
• Test and release in-process control samples used in the manufacturing facility for GMP. Performing analytical analysis and reviewing data for completeness and accuracy
• Maintain a cGMP quality level of work for the QC operations to include training, documentation and procedural work
• Write/revise specifications as necessary, performing analytical analysis and reviewing data for completeness and accuracy
• Write standard operating procedures, standard test procedures and other related GMP documentation
• Implement and maintain GMP procedures such as following written procedure and maintaining proper documentation as necessary for Quality Control
• Perform QC analysis to include: HPLC, UPLC, Water, Mass Spec, UV, GC, melting point, Optical Rotation, TLC and misc. wet chemistry lab work and other related analytical equipment used for control quality of the GMP facility. This work may include calibration and validation of these methods
• Control raw material used in the manufacturing facility for GMP to include receiving, quarantine, testing and QC release
• Investigate any deviation or out of specification as necessary related to QC work performed as instructed by supervisor
• Execute validations as necessary to include QC Analytical methods performed, other validations to support the quality of the manufacturing facility
• Follow safety guidelines for handling, disposal and use for a peptide manufacturing company using toxic and/or large volumes of chemicals
• Support validation, and stability as necessary to include but not limited to analytical work, documentation and quality GMP procedure

Qualifications

• Bachelor's degree in chemistry or related field
• Master's degree in chemistry or related field (preferred)
• Minimum of 3 years' experience in GMP pharma/biotech facility
• Experience with Equipment Maintenance Programs
• Experience with the use of analytical techniques / instruments, including GC, HPLC/UPLC, & UV-Spectrophotometer
• Excellent written and oral communication skills
• Basic computer knowledge, including Microsoft Word, Excel and PowerPoint
• Ability to effectively organize, multitask, and work in a fast-paced, deadline driven work environment
• Ability to communicate in a proactive and solution-focused manner, including keeping management aware of potential issues
• Detail oriented with the ability to troubleshoot and resolve problems
• Ability to work independently and manage one's time
• Communicate effectively and ability to function well in a team environment
• Ability to review Certificate of Analysis for Reagents for the creation of specification documents
• Organization skills to support the department in the creation and approval of controlled documents in a timely manner
• Flexibility of working hours based on business needs, may include some nights and occasional weekends

Base Hourly Range:

• Scientist I: $30.01 - $41.27
• Scientist II: $34.70 - $47.71
• Scientist III: $41,81 - $57.49
• Sr. Scientist: $48.08 - $66.11

Placement of new hires in these wage ranges is based on several factors including education, skill sets, experience, and training.

Total Rewards

We offer all Team Members a total rewards package including competitive pay, annual performance bonus, a generous benefit package with comprehensive Medical/Dental/Vision coverage, 401(k) plan with employer contribution, and paid vacation, personal and sick days.

Corporate Social Responsibility

Bachem takes responsibility for future generations by a careful handling of resources and avoiding environmental risks. We continually improve our ecological performance and develop and implement new approaches for enhancing employees' environmental awareness.EcoVadis has awarded Bachem Gold Medal status in their assessment of Bachem.

Bachem Americas is an Equal Opportunity Employer

As an equal opportunity employer, we celebrate the diversity of our team and are committed to building an inclusive workplace where individuals are hired and advanced based on merit, skills, and qualifications. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity or expression, sexual orientation, national origin, genetics, disability, age, veteran status, or other legally protected status.

PI286613385